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Clozapine Medication Stewardship
Session #50, February 12, 2019
Heather Sulkers, Senior Director, EPMO & Clinical Applications, CAMH
Dr. Tania Tajirian, Chief Medical Informatics Officer, CAMH
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Heather Sulkers, Senior Director, EPMO & Clinical Informatics
AND
Dr. Tania Tajirian, Chief Medical Informatics Officer
Have no real or apparent conflicts of interest to report.
Conflict of Interest
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Agenda
• Origins
• Transformation
• Data-Driven Organization
• Achievements
Introduction
to CAMH
• Local Problem
• Design and Implementation
• How Health IT was used
• Value Derived
Myocarditis
Monitoring
Protocol
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• Describe the objectives and methods of the project to understand
the importance of engaging in standardized risk protocols for
patients taking clozapine
• Summarize key outcomes and/or results and describe the extent
to which the initiative has demonstrated an impact on health
outcomes or health care system performance
• Share implications which may be derived from the results of this
study for other health care organizations
Learning Objectives
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CAMH Overview
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Toronto
Location
CAMH is located in downtown Toronto, Canada
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CAMH Transforming Lives
Largest mental health and addictions
hospital in Canada
University of Toronto - affiliated teaching
hospital
World leader in brain science
3 main sites with 30+ locations
90 distinct services between an
emergency department, inpatient,
outpatient, day treatment and partial
hospitalization models
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CAMH Clinical Programs
Acute Care
Complex Care
and Recovery
Clinical Services
• ED (Emergency
Department) and
Inpatient Services
• Outreach &
Telemedicine
• Ambulatory Services
• CCR Inpatient
Services
• CCR Outpatient
Services
• CCR Specialized
Services and
Research
• Clinical
Operations
• Clinical
Laboratory
and
Diagnostic
Services
• Pharmaceutica
l Services
• Medical
Services
• Hospitalist
Services
• Infection
Prevention
and Control
• Dental Clinic
• Podiatry
Clinics
• Dietetic
Services
• Nursing
Resource Unit
Child, Youth &
Emerging Adult
• Child, Youth &
Emerging Adult
Services
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CAMH Origins - 1848
Provincial Lunatic Asylum
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Merger of Founding Organizations – 1999
Donwood Institute
Queen Street Mental Health Centre
Clarke Institute of Psychiatry
Addiction Research Foundation
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CAMH Key Statistics
2017-2018 Report
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Roadmap to Data-Driven Care
IT Infrastructure
Optimization
Centralized Intake Process
Enterprise
Reporting
Integrated Care Pathways
Krembil Centre for
Neuroinformatics
Clinical Information
System
Transformation
Performance
Improvement / Business
intelligence
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Why the Davies Award?
International recognition that CAMH leverages its clinical information system to support
excellence in care delivery and identify ongoing improvement opportunities, in support of our
overarching strategic vision.
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Monitoring Protocol for
Clozapine-induced
Myocarditis
1
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Agenda
Problem
Identification /
Importance
Baseline
Workflow
Baseline Data
Design and
Implementation
Local Problem
How Health IT was Used
Value Derived
Objectives
Solution Selection
Interventions
End-User
Involvement
Revised Workflow
Solution Details
Effect of Interventions
on Data
Post-Implementation
Adherence Data
Post-Implementation
Outcome Data
Return on Investment
Problem Identification /
Importance
Baseline Workflow
Baseline Data
Objectives
Solution Selection
Interventions
End-User Involvement
Revised Workflow
Solution Details
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Overview of Clozapine
• 25-30% of all individuals with schizophrenia meet
criteria for treatment resistance (Remington 2010)
• Clozapine is the only antipsychotic with proven
efficacy (Remington, Addington et al. 2017)
• Substantial side-effects
Side Effect Prevalence
Agranulocytosis Rare (<1%)
Constipation 60%
Myocarditis <5%
• CAMH houses the largest clozapine clinic in North America (~750 patients)
• Goal to double volume over a 5-year period
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
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Problem Identification
• Clinical symptoms of myocarditis noted in patients treated with clozapine
• An expert was consulted who determined that the cause was myocarditis
• Agranulocytosis is the only standard monitoring for clozapine treatment
Problem Identification
• Clozapine-induced Myocarditis is a potentially fatal yet likely under
diagnosed complication of Clozapine therapy
Incidence estimated ~ 3%
Develops within the first 4 weeks of Clozapine initiation and titration
Hypersensitivity reaction with a fatality rate of 10%
Why is this Important?
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
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Baseline Workflow
Patient
presents
with TRS
Alternative
treatment
prescribed
Continue
treatment
Clozapine
order(s)
entered
Review and
stop
treatment
Decision
to
prescribe
Clozapine
Myocarditis
symptoms?
Can re-
challenge
patient after
1 year
Yes
No
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
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Myocarditis Monitoring
Cardiac Troponin Positive C-Reactive Protein > 50
Suspected myocarditis
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
Baseline Data
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
Nov 2013 – Oct 2014
Myocarditis Monitoring Protocol 4.2%
0% 0% 0% 0% 0% 0% 0% 0%
17%
0% 0% 0%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Nov-13 Dec-13 Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14 Aug-14 Sep-14 Oct-14
Percentage of Patients
Month
Clozapine-naïve Patients with Myocarditis Monitoring Protocol
n = 1
Cardiac
Specialist
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Objectives
Standardize myocarditis monitoring
protocol for Clozapine-naïve patients
Increase compliance to myocarditis
monitoring protocol
Discontinue Clozapine for patients
showing warning signs of myocarditis
Streamline ordering process to save
clinician time and prevent errors
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
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Solution Selection
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
Standardized
practice
Standardized
documentation
Communication
tools
The implementation of I-CARE provided an opportunity to standardize care through order
sets.
-Decision to standardize practice through order sets was made through the Hospitalist User
Group and the Pharmacy and Therapeutics Committee
Tracking and
feedback
Clinician
familiarity
Dynamic
reporting
Existing
change
management
Existing
governance
CAMH identified a method to increase myocarditis monitoring for Clozapine patients.
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• Included Myocarditis
monitoring protocol into
Clozapine policy (Oct. 2014)
Interventions
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
• Integrated Myocarditis
monitoring protocol into
I-CARE order sets (Nov. 2014)
• Reinforced education with
cardiology expert (Apr. 2015);
monitoring protocol elements
made mandatory within
I-CARE order sets (Jun. 2015)
Policy Order Sets
Mandatory Fields
(Locking)
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Strategic Governance
** Advisory / Working Groups established as
required
High-level Decisions
Mid-Level
Decisions
Medical Advisory
Committee
Physician in Chief
Health Information
Interdisciplinary
Committee
Dir. Interprof. Practice
Dir. Medical Informatics
Executive Leadership
Team
CEO
Physician /
Hospitalist User
Groups
Dir. Medical Informatics
Lead Hospitalist
Pharmacy &
Therapeutics
Dir. Pharmacy
Order Sets
Sub-Committee
Dir. Medical
Informatics
Pharmacist
Practice Adoption &
Optimization Council
Manager, Clinical
Education
Advanced Practice
Clinical Lead
Clinical Applications
Change Advisory
Board
Sr. Manager, Clinical
Applications
Data and Reporting
Governance Committee
(ELT Sub-Committee)
Exec. Dir. Performance
Improvement
Med. Dir. Performance
Improvement
Collaborative Practice
Advisory Committee
Chief of Nursing
APPROVED
Clinical Care Committee
Dir. Interprofessional
Practice
Chief Medical Officer
Integrated Health Record Council
Dir. Clinical Information Systems
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
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• Chair: Medical Head, Hospitalist Services
• Developers and subject matter experts for Clozapine
Order Sets
• Representation from physicians, nurses, Pharmacy,
Professional practice, and Health Records
• Chair: Chief Medical Information Officer
• Representation of front-line physicians
• Contains 15 physicians from throughout CAMH
End-User Involvement
Hospitalist User Group
Physician User Group
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
• Co-chairs: Appointed Physician and Dir. Pharmacy
• Owners and approvers of Order Set
• Includes a minimum of 6 physicians, 4 pharmacists
Pharmacy & Therapeutics
• Chairs: Dir. Interprofessional Practice, Dir. Medical
Informatics
• Includes clinicians and other stakeholders
• Initial approval of need
Integrated Health Record
Committee
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Pre-
Clozapine
Initiation
Order Set
(Baseline)*
Mandatory
blood work
for 4 weeks*
Select
Clozapine
with Titration
or Clozapine
without
Titration
Order Set*
Health IT used within intervention*
Revised Workflow
Patient
presents with
TRS
Alternative
treatment
prescribed
Continue
treatment
Review and
stop
treatment
Decision
to
prescribe
Clozapine
Results
normal or
abnormal
?
Can re-
challenge
patient after
1 year
Abnormal
Normal
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
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Mandatory Monitoring Protocol
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• Baseline ECG, CRP, and Troponin
• Identification of pre-existing cardiac disease
Pre-initiation
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
Troponin lab test
CRP lab test
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Mandatory Monitoring Protocol
2
Troponin lab test CRP lab test
4 week duration
*
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
• Weekly clinical assessments
• CRP and Troponin monitoring x 4 weeks
• Regular Agranulocytosis monitoring
Post-initiation
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Effect of Interventions on Data
2
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
Policy Order Sets
Mandatory Fields
(Locking)
• Included Myocarditis
monitoring protocol into
Clozapine policy
(Oct. 2014)
• Integrated Myocarditis
monitoring protocol into
I-CARE order sets
(Nov. 2014)
• Reinforced education with
cardiology expert (Apr.
2015); monitoring protocol
elements made mandatory
within I-CARE order sets
(Jun. 2015)
Intervention
Effect
• Increased clinical
awareness and regulations
to educate staff about
clozapine-induced
myocarditis and the
effective monitoring protocol
• Integration of monitoring
protocol increased speed of
ordering and provided a
visual reminder about the
monitoring protocol for
clinicians
• Increased clinical
awareness and enforced
regulations to standardize
practice for Clozapine-naïve
patients
0% 0% 0%
7%
88%
100% 100% 100%
89%
100%
95%
100% 100% 100% 100%
97%
94%
89%
100%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
110%
2013
Q4
2014
Q1
2014
Q2
2014
Q3
2014
Q4
2015
Q1
2015
Q2
2015
Q3
2015
Q4
2016
Q1
2016
Q2
2016
Q3
2016
Q4
2017
Q1
2017
Q2
2017
Q3
2017
Q4
2018
Q1
2018
Q2
Percentage of Patients
Calendar Quarter
Clozapine-naive Patients with Myocarditis Monitoring Protocol
Policy
Order
Sets
Locking
Post-Implementation Adherence Data
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
Nov 2013 – Oct 2014 Nov 2014 – May 2018
Myocarditis Monitoring Protocol 4.2% 97.0%
Pre-implementation
Post-implementation
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Post-Implementation Outcome Data
3
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
0
27
0
5
10
15
20
25
30
Number of Patients
Number of patients discontinued from
Clozapine due to suspected Myocarditis
Nov 2013 - Oct 2014 Nov 2014 - May 2018
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Discontinued Patient Demographics
3
1
2
1 1 1
13
2 2
4
0
2
4
6
8
10
12
14
16
Less than 21 21 to 32 33 to 42 43 to 53 53 to 64
Number of Patients
Age
Number of Clozapine Patients with Myocarditis Risk by Age and Sex
Female Male
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
*13.5%
*13 / 96 (13.5%) of males aged 21 to 32 discontinued
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Return on Investment
3
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
Twenty-seven Clozapine-naïve patients had suspected myocarditis detected in early stages.
Savings = (Cost of adverse event * # of patients detected)
Patients on Clozapine with
Myocarditis Monitoring
Flagged as at risk and taken off
Clozapine
n = 27
Cost
averted =
$108,756
n =283
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Return on Investment
3
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
Able to measure
the true incidence
(8.6%) of
Clozapine-induced
myocarditis; 27
patients removed
from Clozapine
due to warning
signs
Clinicians are able
to more easily
screen for
Clozapine
associated
Myocarditis
Developed
guidelines for
Clozapine
cessation and
reintroduction
CAMH is locally
leading the way for
Clozapine-induced
myocarditis
monitoring and we
expect uptake on
a regional and
national level after
publishing
27 patients removed from Clozapine due to myocarditis warning signs (3 lives saved)
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Lessons Learned
3
Policy change can be supported by health
IT to support adoption and enforcement
Order sets are effective at driving adoption
of mandatory protocols
Data sharing with clinicians is an effective
method for practice awareness
Design and
Implementation
Local Problem
How Health IT
was Used
Value Derived
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• Insert mental health is health slide
